Reconstitution assembly, locking device and method for a diluent container

Abstract

A reconstitution assembly includes: a flexible bag containing a diluent; a drug vial containing a drug; a reconstitution device further comprising: a first sleeve connected to the first container; a second sleeve connected to the second container, the second sleeve being associated with the first sleeve and movable axially with respect thereto from an inactivated position to an activated position; a piercing member positioned in the sleeves, the piercing member providing a fluid pathway between the bag and vial when the sleeves are in the activated position.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This is a divisional application of U.S. application Ser. No. 10 / 744,953 filed Dec. 23, 2003, which is a continuation-in-part application of U.S. application Ser. No. 10 / 106,716 filed Mar. 26, 2002, now U.S. Pat. No. 7,074,216, patented Jul. 11, 2006, which is a continuation-in-part application of U.S. application Ser. No. 09 / 561,666, filed May 2, 2000, now U.S. Pat. No. 6,582,415, patented Jun. 24, 2003, which is a continuation application of U.S. application Ser. No. 09 / 153,816, filed Sep. 15, 1998, now U.S. Pat. No. 6,113,583, patented Sep. 5, 2000, which applications are incorporated herein by reference and made a part hereof.TECHNICAL FIELD[0002]The present invention relates generally to the delivery of a beneficial agent to a patient. More specifically, the present invention relates to an improved device for reconstituting a beneficial agent to be delivered to a patient.BACKGROUND[0003]Many drugs are unstable even for a short period...

AI Technical Summary

Benefits of technology

[0034]According to another aspect of the invention, the thickened center hub substantially blocks the central fluid passageway of the piercing member as the center hub is penetrated by the piercing member but before the piercing member completely penetrates the piercing center hub.

[0049]According to another aspect of the invention, one of the first sleeve and the second sleeve may contain a lubricant additive that assists in providing a more uniform activation force. In one preferred embodiment, the first sleeve has a sleeve ridge and the second sleeve has a sleeve rib. One of the sleeve ridge and the sleeve rib has the lubricant additive. The second sleeve may have a discontinuous annulus to further assist in providing a more uniform activation force.

Problems solved by technology

In some procedures for reconstituting, maintaining sterile conditions is difficult.

Moreover, some drugs, such as chemotherapy drugs, are toxic and exposure to the medical personnel during the reconstitution procedure can be dangerous.

However, no seal was provided on the opposite end of the connector so the vial and device assembly had to be used immediately after connection or stored in a sterile environment, such as under a hood.

However, it is possible for the device of the 209 patent to be easily and inadvertently disassembled when being moved to the activated position.

Also, the device of the '209 patent did not provide for a visual indication that the device was in the activated position.

This could cause coring of the vial stopper which could lead to leakage of the vial stopper.

Additionally it was possible for a vial to be misaligned while being attached to the device causing the attachment process to be difficult for medical personnel.

Further, the connector only releasably attached to the vial.

Removal of the vial could remove all tamper evident indications that the reconstitution step has occurred and could lead to a second unintended dosage of medicine to be administered.

However, tamper evident marks will not be left in vials that have a cap that is too short to impinge upon the sharp points.

However, because the spike 25 extends outward beyond skirt sections 57, the connector of the '020 patent cannot be preattached to the fluid container or the drug container without piercing the stoppers of each.

This is undesirable as it initiates the time period in which the drug must be used, and typically this is a short period relative to the normal shelf-life of the product.

Also, the connector of the '020 patent does not provide a structure for preventing a docked vial from rotating.

A closure of the vial can become damaged or cored upon rotation, which in turn, can lead to particles from the closure from entering the fluid that eventually passes to a patient.

It can also lead to leakage of the closure of the vial.

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